Dose Confirmation and Dose Expansion Phase 1 Study of IO-108 and IO-108 + Anti-PD-1 in Solid Tumors
- Conditions
- Advanced Solid Tumor
- Interventions
- Biological: IO-108Biological: IO-108 + pembrolizumabBiological: IO-108 + tislelizumab
- Registration Number
- NCT05508100
- Lead Sponsor
- Immune-Onc Therapeutics
- Brief Summary
This is a Phase 1 study to evaluate the safety, tolerability, PK, and preliminary efficacy of IO-108 monotherapy and in combination with anti-PD-1 monoclonal antibody pembrolizumab or tislelizumab in adult patients with advanced solid tumors. The study will be conducted in 3 parts, including Part A IO-108 monotherapy dose confirmation; Part B IO-108 + anti-PD-1 dose confirmation, and Part C dose expansion.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 38
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Age ≥18, and < 75.
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Part A and Part B Cohort 1: Patients must have histologically or cytologically confirmed advanced or metastatic solid tumor and have failed, or have been intolerant for standard systemic therapy, or for whom no treatment known to confer clinical benefit exists.
Part B Cohort 2 and Part C: Patient with advanced or metastatic solid tumor who meet the specific criteria.
-
Patients have at least 1 measurable disease per RECIST v1.1 as assessed by local clinical site.
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Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.
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Patients must have adequate hematologic function, hepatic function and renal function.
- Patients who previously received a monoclonal antibody therapy targeting LILRB2/ILT4 (including IO-108).
- Patients who received chemotherapy, radiotherapy, biologic therapy, targeted therapy, immunotherapy, or other investigational anti-cancer therapy < 4 weeks prior to their first day of study drug administration.
- Requires systemic corticosteroids at a dose of >10 mg daily of prednisone or the dose equivalent to other systemic corticosteroid, or other immunosuppressive agents ≤ 14 days prior to the first dose.
- History of radiation pneumonitis, non-infectious pneumonitis or interstitial lung disease expect for radioactive pulmonary fibrosis not requiring corticosteroid treatment.
- Symptomatic central nervous system (CNS) metastases. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: IO-108 monotherapy dose confirmation IO-108 Patients with advanced or metastatic solid tumors will be enrolled and treated with IO-108, intravenously, every 21 days. Part B: IO-108 + anti-PD-1 dose confirmation. IO-108 + tislelizumab Patients will receive IO-108 in combination with with a fixed dose of pembrolizumab, intravenously, every 21 days; Patients will receive IO-108 in combination with with a fixed dose of tislelizumab, intravenously, every 21 days. Part C: Dose expansion IO-108 + pembrolizumab Patients with advanced or metastatic solid tumors who meet the specific criteria will be enrolled into one of the cohorts. Part B: IO-108 + anti-PD-1 dose confirmation. IO-108 + pembrolizumab Patients will receive IO-108 in combination with with a fixed dose of pembrolizumab, intravenously, every 21 days; Patients will receive IO-108 in combination with with a fixed dose of tislelizumab, intravenously, every 21 days. Part C: Dose expansion IO-108 + tislelizumab Patients with advanced or metastatic solid tumors who meet the specific criteria will be enrolled into one of the cohorts.
- Primary Outcome Measures
Name Time Method Preliminary anti-tumor activity of IO-108 in combination with pembrolizumab or tislelizumab through study completion, an average of 2 years ORR is defined as the percentage of patients who have a complete response (CR) or a partial response (PR) per RECIST v1.1
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) in patients treated with IO-108 through study completion, an average of 2 years AE severity graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0
Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) in patients treated with IO-108 in combination with pembrolizumab or tislelizumab through study completion, an average of 2 years AE severity graded by NCI CTCAE, Version 5.0
- Secondary Outcome Measures
Name Time Method Preliminary anti-tumor activity through study completion, an average of 2 years Progression-free Survival, defined as the time interval from the first dose date to the occurrence of disease progression or death of any cause
Steady state concentration of IO-108 through study completion, an average of 2 years Characterize steady state concentration of IO-108 by successive sampling of blood at pre-specified time points
Anti-drug antibodies (ADA) of IO-108 through study completion, an average of 2 years Determine the incidence and titer of ADAs against IO-108
Maximum plasma concentration (Cmax) of IO-108 through study completion, an average of 2 years Characterize the Cmax of IO-108 by successive sampling of blood at pre-specified time points
Trial Locations
- Locations (14)
Harbin Cancer Hospital
🇨🇳Harbin, Heilongjiang, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Liaoning Cancer Hospital
🇨🇳Shenyang, Liaoning, China
Shandong Cancer Hospital
🇨🇳Jinan, Shandong, China
1st Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xian, Shanxi, China
4th Hospitla of Hebei Medical University
🇨🇳Shijia Zhuang, Hebei, China
Tongji Hospital
🇨🇳Wuhan, Hubei, China
1st affiliated Hospital of Hainan Medical University
🇨🇳Haikou, Hainan, China
Lin Yi Cancer Hospital
🇨🇳Linyi, Shandong, China
The First Affiliated Hospital of Fujian Medical University
🇨🇳Fujian, Fuzhou, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
Hunan Cancer Hospital
🇨🇳Changsha, Hunan, China
Shanghai Dong Fang Hospital
🇨🇳Shanghai, Shanghai, China
Sir RUN RUN SHAW HOSPITAL
🇨🇳Hangzhou, Zhejiang, China